5. Product Control
5.1. Layout, Product Flow and Segregation
FUNDAMENTAL
1
Clause 5.1.1
The company shall provide clear guidelines on any restrictions to the scope of new product developments to control the introduction of hazards which would be unacceptable to the site or customers (e.g. the introduction of allergens, glass packaging or microbiological risks).
Outcome Docs Actions Notes
Yes No N/A
Are there clear guidelines on any restrictions to the scope of new product developments to control the introduction of hazards which would be unacceptable to the site or customers?
Clause 5.1.2
All new products and changes to product formulation, packaging or methods of processing shall be formally approved by the HACCP team leader or authorised HACCP committee member. This shall ensure that hazards have been assessed and suitable controls, identified through the HACCP system, are implemented. This approval shall be granted before products are introduced into the factory environment.
Outcome Docs Actions Notes
Yes No N/A
Are all new products formally approved by the HACCP team leader or authorised HACCP committee member?
Are all changes to product formulation, packaging or methods or processing formally approved by the HACCP team leader or authorised HACCP committee member?
Does the approval ensure that hazards have been assessed?
Does the approval ensure that suitable controls, identified through the HACCP system, are implemented?
Is the approval granted before products are introduced into the factory environment?
Clause 5.1.3
Trials using production equipment shall be carried out where it is necessary to validate that product formulation and manufacturing processes are capable of producing a safe product of the required quality.
Outcome Docs Actions Notes
Yes No N/A
Are trials using production equipment carried out when it is necessary to validate that product:
Clause 5.1.4
Initial shelf-life trials shall be undertaken using documented protocols that reflect conditions expected during manufacture, storage, transport/distribution, use and handling to determine product shelf life.
Outcome Docs Actions Notes
Yes No N/A
Are initial shelf-life trials undertaken using documented protocols, to determine product shelf life, that reflect conditions expected during:
Are results recorded?
Are results retained?
Do results confirm compliance with the relevant:
Where shelf-life trials prior to production are impractical, is a documented science-based justification for the assigned shelf life produced?
5.2. Layout, Product Flow and Segregation in High-Risk, High-Care and Ambient High-Care Zones.
FUNDAMENTAL
1
Clause 5.2.1
All products shall be labelled to meet legal requirements for the designated country of use and shall include information to allow the safe handling, display, storage, preparation and use of the product within the food supply chain or by the customer. There shall be a process to verify that ingredient and allergen labelling is correct based on the product recipe and ingredient specifications.
Outcome Docs Actions Notes
Yes No N/A
Are all products labelled to meet legal requirements for the designated country of use?
Do all product labels include information to allow, within the food supply chain or by the customer:
Is there a process to verify that ingredient labelling is correct based on the: - product recipe?
Is there a process to verify that allergen labelling is correct based on the:
Clause 5.2.2
There shall be effective processes in place to ensure that labelling information is reviewed whenever changes occur to:
Outcome Docs Actions Notes
Yes No N/A
Are there effective processes to ensure that labelling information is reviewed whenever changes occur to:
Clause 5.2.3
Where a product is designed to enable a claim to be made to satisfy a consumer group (e.g. a nutritional claim, reduced sugar), the company shall ensure that the product formulation and production process are fully validated to meet the stated claim.
Outcome Docs Actions Notes
Yes No N/A
Where a product is designed to enable a claim to be made to satisfy a consumer group, are the:
Clause 5.2.4
Where the label information is the responsibility of a customer or a nominated third party, the company shall provide information:
Outcome Docs Actions Notes
Yes No N/A
Where the label information is the responsibility of a customer or a nominated third party, is information:
Clause 5.2.5
Where cooking instructions are provided to ensure product safety, they shall be fully validated to ensure that, when the product is cooked according to the instructions, a safe, ready-to-eat product is consistently produced.
Outcome Docs Actions Notes
Yes No N/A
Where cooking instructions are provided to ensure product safety, are they fully validated to ensure that, when the product is cooked according to the instructions, a safe, ready-to-eat product is consistently produced?
5.3. List all potential hazards associated with each process step, conduct a hazard analysis and consider any measures to control identified hazards (equivalent to Codex Alimentarius Step 6, Principle 1)
FUNDAMENTAL
1
Clause 5.3.1
The site shall carry out an assessment of raw materials to establish the presence and likelihood of contamination by allergens (see glossary). This shall include a review of the raw material specifications and, where required, the acquisition of additional information from suppliers (e.g. through questionnaires to understand the allergen status of the raw material, its ingredients and the factory in which it is produced).
Outcome Docs Actions Notes
Yes No N/A
Is an assessment of raw materials carried out to establish the:
Do these assessments include a review of the raw material specifications?
Do these assessments include, where required, the acquisition of additional information from suppliers?
Clause 5.3.2
The company shall identify and list allergen-containing materials handled on site. This shall include raw materials, processing aids, intermediate and finished products, and any new product development ingredients or products.
Outcome Docs Actions Notes
Yes No N/A
Have the allergen-containing materials handled on site been identified?
Is there a list of allergen-containing materials handled on site?
Does the list include:
Clause 5.3.3
A documented risk assessment shall be carried out to identify routes of contamination and establish documented policies and procedures for handling raw materials and intermediate and finished products to ensure cross-contamination (cross-contact) is avoided. This assessment shall include:
Outcome Docs Actions Notes
Yes No N/A
Is a documented risk assessment carried out to identify routes of contamination?
Does the risk assessment establish the following, to ensure cross-contamination is avoided?
Does the risk assessment include:
Clause 5.3.4
Procedures shall be established to ensure the effective management of allergenic materials to prevent cross-contamination (cross-contact) of products not containing the allergen. These shall include, as appropriate:
Outcome Docs Actions Notes
Yes No N/A
Are there procedures established to ensure the effective management of allergenic materials to prevent cross-contamination of products not containing the allergens?
Do these procedures include, as appropriate:
Clause 5.3.5
Where rework is used, or reworking operations are carried out, procedures shall be implemented to ensure rework containing allergens is not used in products that do not already contain the allergen.
Outcome Docs Actions Notes
Yes No N/A
Where rework is used, or reworking operations are carried out, are procedures implemented to ensure rework containing allergens is not used in products that do not already contain the allergen?
Clause 5.3.6
Where a justified, risk-based assessment demonstrates that the nature of the production process is such that cross-contamination (cross-contact) from an allergen cannot be prevented, a warning should be included on the label. National guidelines or codes of practice shall be used when making such a warning statement.
Outcome Docs Actions Notes
Yes No N/A
Where a justified, risk-based assessment demonstrates that the nature of the production process is such that cross-contamination from an allergen cannot be prevented, is a warning included on the label?
Are national guidelines or codes of practice used when making such a warning statement?
Clause 5.3.7
Where a claim is made regarding the suitability of a food for allergy or food sensitivity sufferers, the site shall ensure that the production process is fully validated to meet the stated claim and the effectiveness of the process is routinely verified. This shall be documented.
Outcome Docs Actions Notes
Yes No N/A
Where a claim is made regarding the suitability of a food for allergy or food sensitivity sufferers, is it ensured that the:
Is this documented?
Clause 5.3.8
Equipment or area-cleaning procedures shall be designed to remove or reduce to acceptable levels any potential cross-contamination (cross-contact) by allergens. The cleaning methods shall be validated to ensure that they are effective and the effectiveness of the procedure routinely verified. Cleaning equipment used to clean allergenic materials shall either be identifiable and specific for allergen use, single use, or effectively cleaned after use.
Outcome Docs Actions Notes
Yes No N/A
Are equipment or area-cleaning procedures designed to remove or reduce to acceptable levels any potential cross-contamination by allergens?
Are the cleaning methods validated to ensure that they are effective?
Is the effectiveness of the cleaning methods procedure routinely verified?
Is cleaning equipment used to clean allergenic materials either identifiable and specific for allergen use, single use, or effectively cleaned after use?
5.4. Magnets
FUNDAMENTAL
1
Clause 5.4.1
The company shall have processes in place to access information on historical and developing threats to the supply chain which may present a risk of adulteration or substitution of raw materials (i.e. fraudulent raw materials). Such information may come from, for example:
Outcome Docs Actions Notes
Yes No N/A
Are there processes in place to access information on:
Are trade associations accessed for such information?
Are government sources accessed for such information?
Are private resource centres accessed for such information?
Clause 5.4.2
A documented vulnerability assessment shall be carried out on all food raw materials or groups of raw materials to assess the potential risk of adulteration or substitution. This shall take into account:
Outcome Docs Actions Notes
Yes No N/A
Is a documented vulnerability assessment carried out on all food raw materials or groups of raw materials to assess the potential risk of adulteration or substitution?
Does the assessment take into account:
Is the output from this assessment a documented vulnerability assessment plan?
Is the plan kept under review to reflect:
Is the plan formally reviewed annually?
Clause 5.4.3
Where raw materials are identified as being at particular risk of adulteration or substitution, the vulnerability assessment plan shall include appropriate assurance and/or testing processes to mitigate the identified risks.
Outcome Docs Actions Notes
Yes No N/A
Where raw materials are identified as being at particular risk of adulteration or substitution, does the vulnerability assessment plan include appropriate assurance and/or testing processes to mitigate the identified risks?
Clause 5.4.4
Where products are labelled or claims are made on finished packs which are dependent on the status of a raw material, the status of each batch of the raw material shall be verified. These claims include:
Outcome Docs Actions Notes
Yes No N/A
Where products are labelled or claims are made on finished packs which are dependent on the status of a raw materials, is the status of each batch of the raw material verified?
Are claims about specific provenance or origin verified?
Are breed/varietal claims verified?
Are claims about assured status verified?
Are claims about genetically modified organism status verified?
Are claims about identity preservation verified?
Are claims about named specific trademarked ingredients verified?
Are purchasing records to substantiate claims maintained?
Are traceability of raw material usage records to substantiate claims maintained?
Are final product packing records to substantiate claims maintained?
Are there documented mass balance tests at a frequency to meet the particular scheme requirements OR at least every 6 months in the absence of a scheme-specific requirement undertaken?
Clause 5.4.5
Where claims are made about the methods of production (e.g. organic, halal, kosher) the site shall maintain the necessary certification status in order to make such a claim.
Outcome Docs Actions Notes
Yes No N/A
Where claims are made about the methods of production, is the necessary certification status maintained in order to make such a claim?
Clause 5.4.6
The process flow for the production of products where claims are made shall be documented and potential areas for contamination or loss of identity identified. Appropriate controls shall be established to ensure the integrity of the product claims.
Outcome Docs Actions Notes
Yes No N/A
Is the process flow for the production of products where claims are made documented?
Are potential areas for contamination or loss of identity in the process flow for the production of products identified?
Are appropriate controls established to ensure the integrity of the product claims?
5.6. Maintenance
FUNDAMENTAL
1
Clause 5.6.1.1
There shall be a scheduled programme of product testing which may include microbiological, chemical, physical and organoleptic testing according to risk. The methods, frequency and specified limits shall be documented.
Outcome Docs Actions Notes
Yes No N/A
Is there a scheduled programme of product testing which may include microbiological, chemical, physical and organoleptic testing in accordance to risk?
Are the methods of product testing documented?
Is the frequency of product testing documented?
Are the specified limits of product testing documented?
Clause 5.6.1.2
Test and inspection results shall be recorded and reviewed regularly to identify trends. The significance of external laboratory results shall be understood and acted upon accordingly. Appropriate actions shall be implemented promptly to address any unsatisfactory results or trends.
Outcome Docs Actions Notes
Yes No N/A
Are test results recorded to identify trends?
Are test results reviewed regularly to identify trends?
Are inspection results recorded to identify trends?
Are inspection results reviewed regularly to identify trends?
Is the significance of external laboratory results understood?
Is the significance of external laboratory results acted upon accordingly?
Are appropriate actions implemented promptly to address unsatisfactory results or trends?
Clause 5.6.1.3
The site shall ensure that a system of validation and ongoing verification of the shelf life is in place. This shall be based on risk and shall include sensory analysis and, as applicable, microbiological testing and relevant chemical factors such as pH and aw. Records and results from shelf-life tests shall verify the shelf-life period indicated on the product.
Outcome Docs Actions Notes
Yes No N/A
Is there a system of validation of the shelf life in place?
Is there a system of ongoing verification of the shelf life in place?
Are these systems based on risk?
Do these systems include:
Do records from shelf-life tests verify the shelf-life period indicated on the product?
Do records from shelf-life tests verify the shelf-life period indicated on the product?
Clause 5.6.2.1
Pathogen testing (including pathogens tested as part of the environmental testing) shall be subcontracted to an external laboratory or, where conducted internally, the laboratory facility shall be fully segregated from the production and storage areas and have operating procedures to prevent any risk of product contamination.
Outcome Docs Actions Notes
Yes No N/A
Is pathogen testing subcontracted to an external laboratory?
Where conducted internally:
Clause 5.6.2.2
Where routine testing laboratories are present on a manufacturing site, they shall be located, designed and operated to eliminate potential risks to product safety. Controls shall be documented, implemented and include consideration of:
Outcome Docs Actions Notes
Yes No N/A
Where routine testing laboratories are present on a manufacturing site, are they:
Are controls documented?
Are controls implemented?
Do controls include consideration of design of:
Clause 5.6.2.3
Where the company undertakes or subcontracts analyses which are critical to product safety or legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and principles of ISO/IEC 17025. Documented justification shall be available where accredited methods are not undertaken.
Outcome Docs Actions Notes
Yes No N/A
Where the company undertakes or subcontracts analyses which are critical to product safety or legality, do the laboratory or subcontracts have recognised laboratory accreditation or operate in accordance with the:
- principles of ISO/IEC 17025?
Is documented justification available where accredited methods are not undertaken?
Clause 5.6.2.4
Procedures shall be in place to ensure reliability of laboratory results, other than those critical to safety and legality specified in clause 5.6.2.3. These shall include:
Outcome Docs Actions Notes
Yes No N/A
Are procedures in place to ensure reliability of laboratory results, other than those critical to:
legality specified in clause 5.6.2.3?
Do these procedures include:
Clause 5.6.2.5
The significance of laboratory results shall be understood and acted upon accordingly.
Outcome Docs Actions Notes
Yes No N/A
Is the significance of laboratory results:
Is appropriate action taken promptly to address any unsatisfactory results or trends?
Where legal limits apply:
5.7. Maintenance in High-Risk and High-Care zones
FUNDAMENTAL
1
Clause 5.7.1
Where products require positive release, procedures shall be in place to ensure that release does not occur until all release criteria have been completed and the release has been authorised.
Outcome Docs Actions Notes
Yes No N/A
Where products require positive release, are procedures in place to ensure that release does not occur until:
5.8. Management of Allergens
FUNDAMENTAL
1
Clause 5.8.1
The site shall ensure pet food is formulated/designed for the intended use (e.g. where products are designed for complete diet or as a complementary product).
Outcome Docs Actions Notes
Yes No N/A
Is pet food formulated/designed for the intended use?
Clause 5.8.2
Where a site's product range includes pet food products for different animal species, the site shall have specific procedures for the management of any ingredients, raw materials, products or rework that could be harmful to unintended recipients.
Outcome Docs Actions Notes
Yes No N/A
Where the site's product range includes pet food products for different animal species, are there specific procedures for the management of any ingredients, raw materials, products or rework that could be harmful to unintended recipients?
Clause 5.8.3
Where the site manufactures, processes or packs pet food products that contain medicinal substances, the site shall have specific procedures for the management of the medicated raw materials and finished products. At a minimum, these procedures shall include:
Outcome Docs Actions Notes
Yes No N/A
Where the site manufactures, processes or packs pet food products that contain medicinal substances, are there specific procedures for the management of:
Do these processes include: